Treatment of ARA290 in neuropathic pain patients.

Effectiveness of ARA290 on pain relief in sarcoidosis patients with small-fiber neuropathy: A randomized controlled trial.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28997

Enrollment

Registered

2011-09-27

Start date

2011-10-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Treatment with the novel drug ARA290 three times a week for 4 consecutive weeks. The dose for every treatment day will be 2 mg. The control group will receive a placebo.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with sarcoidosis induced small-fiber neuropathy; 2. A pain score of 5 or higher; 3. Age between 18 and 75 years; 4. Being able to give written informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnancy; 2. Use of erythropoeitin; 3. Current use of anti-TNF or use within the passed six months; 4. Unable to give written informed consent.

Design outcomes

Primary

Measure	Time frame
Pain relief by VAS scores (scale 0 (no pain) to 10 (most pain imaiganable) of most pain, least pain and average pain by questionnaire.	—

Secondary

Measure	Time frame
Questionnaires evaluating: 1. Severity of small fiber neuropathy; 2. Severity of malaise; 3. Quality of life; 4. Depressive symptoms.	—

Contacts

Public ContactAlbert Dahan

Leiden University Medical Center (LUMC), Department of Anesthesiology, P.O. Box 9600

a.dahan@lumc.nl+31 (0)71 5262301

Outcome results